The efficacy and safety of strontium ranelate versus placebo in the treatment of knee osteoarthritis
| ISRCTN | ISRCTN92624244 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92624244 |
| Protocol serial number | CL3-12911-022 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 11/03/2010
- Registration date
- 14/04/2010
- Last edited
- 28/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Prof Feng Chun Zhang
Scientific
Scientific
Rheumatology and Clinical Immunology Division
Department of Medicine
Peking Union Medical College Hospital
Chinese Academy of Medical Science
No.1 Shuaifuyuan, Wangfujing
Beijing
100730
China
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind parallel-group placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The efficacy and safety of two doses of strontium ranelate versus placebo administered orally for 3 years in the treatment of knee osteoarthritis: a prospective multicentre, international, double-blind, placebo-controlled study |
| Study objectives | To demonstrate the superiority of strontium ranelate versus placebo against articular cartilage damage progression over three years in men and women with knee osteoarthritis. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Osteoarthritis |
| Intervention | The treatment is composed of two doses of strontium ranelate (1 g and 2 g per day) administered orally for 3 years. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Strontium ranelate |
| Primary outcome measure(s) |
Radiographic assessment of knee osteoarthritis measured up to 36 months |
| Key secondary outcome measure(s) |
Measured up to 36 months: |
| Completion date | 30/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 450 |
| Key inclusion criteria | 1. Asia men and women of at least 50 years of age 2. Primary knee osteoarthritis |
| Key exclusion criteria | 1. Knee prosthesis already implanted or foreseen within the next year 2. Hip prosthesis recently implanted (less than 1 year) or not well-tolerated, or foreseen within the next year |
| Date of first enrolment | 30/06/2008 |
| Date of final enrolment | 30/04/2013 |
Locations
Countries of recruitment
- China
- Korea, South
- Taiwan
Study participating centre
Rheumatology and Clinical Immunology Division
Beijing
100730
China
100730
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/03/2018: Publication plan and IPD sharing statement amended.
24/01/2018: Publication plan and IPD sharing statement added.
06/12/2017: results summary added.
